P300 Brain Computer Interface Keyboard to Operate Assistive Technology

NCT00860951 | Completed Phase 1 Results

• 3 other identifiers: H0002 - AT P300 Keyboard Study5R21HD054697H133G090005
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to develop tools enable people who are paralyzed to operate technology and access computers. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology.

Conditions

Healthy; Amyotrophic Lateral Sclerosis; Neuromuscular Disease; Spinal Cord Injury; Cerebral Palsy

Keywords

Normal

Outcome Measures

Primary Outcomes (1)

• Accuracy of Typing With BCI Keyboard.

  Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character. Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.

  mean score from 3 sessions over 29 days

Study Arms (1)

Brain Computer Interface Keyboard

OTHER

What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?

Device: Brain Computer Interface Keyboard

Interventions

Brain Computer Interface Keyboard DEVICE

Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Brain Computer Interface Keyboard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Able to read text on a computer screen
• Able to understand and remember instructions concerning participation

You may not qualify if:

• Unable give informed consent.
• Unable to understand and follow instructions.
• Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
• Known to have photosensitive epilepsy.
• Open head lesions or sores

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• U.S. Department of Education: collaborator

Study Sites (2)

University of Michigan Direct Brain Interface Project

Ann Arbor, Michigan, 48109, United States

Location

Wadsworth Center

Albany, New York, 12201, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases; Spinal Cord Injuries; Cerebral Palsy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Brain Diseases

Results Point of Contact

• Title: Jane Huggins
• Organization: University of Michigan

janeh@umich.edu

734-936-7177

Study Officials

• Jane Huggins, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 13, 2009
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 9, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-05

Locations

US (2)